FDA Orders Tissue Bank To Recall Most Human Tissue

FDA officials yesterday ordered CryoLife Inc., a Georgia-based tissue bank, to recall all human tissue, with the exception of heart valves, distributed since Oct. 3 and to "destroy or stop distributing almost all tissue from its inventory," the Minneapolis Star Tribune reports. In March and April, an FDA investigation found that CryoLife, which distributes ligaments, tendons, bones and other tissues, could not "ensure that its tissue was free of contaminants" and that the company's systems to detect bacteria and other contaminants "were deficient and not reliable." On June 17, the FDA sent a warning letter to CryoLife that outlined the problems and asked the company to address them (Burcum/Marcotty, Minneapolis Star Tribune, 8/15). According to Mary Malarkey, director of case management for the FDA Office of Compliance and Biologics Quality, CryoLife did not respond in "ways that assure that their material is not bacterially contaminated," which led to the recall order (Blakeslee, New York Times, 8/15). The FDA launched the investigation after a CDC probe found that CryoLife distributed the infected tissue used last November in the knee surgery of a 23-year-old Minnesota resident who died days after the operation as a result. In addition, the CDC investigation found 53 similar infections from soft tissue grafts, and 26 involved tissue distributed by CryoLife (Kaufman, Washington Post, 8/15). CryoLife officials said that they have appealed the FDA recall order (Minneapolis Star Tribune, 8/15). In the appeal, CryoLife asked for a stay on the destruction of tissue. The FDA has 30 days to set a hearing date, the Atlanta Journal-Constitution reports (McNaughton/McKenna, Atlanta Journal-Constitution, 8/15).

FDA officials and medical experts said that the CryoLife recall will not lead to a shortage of tissue for knee surgery patients (Minneapolis Star Tribune, 8/15). However, FDA officials said that "there may be some disruption" in the tissue market as a result of the recall (Adams, Wall Street Journal, 8/15). Meanwhile, CDC officials warned that patients who have received recent tissue grafts should not "rush to have grafts removed." The agency cited the low rate of infections in tissue transplant surgeries. However, patients who received tissue grafts should "notify their doctors immediately if they notice signs of possible infection," CDC officials said (Atlanta Journal-Constitution, 8/15).